Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that specializes in advancing novel gene therapies from concept to commercialization.  Located in Columbus, OH, the company operates out of the Andelyn Corporate Center (ACC) for clinical and commercial cGMP manufacturing of viral vectors and plasmids and the Andelyn Development Center (ADC) for preclinical non-cGMP activities.

 Our Values are founded in our origin story.

The name “Andelyn” is a hybrid of two gene therapy patients who participated in pivotal Phase I clinical trials at Nationwide Children’s Hospital. Andrew received the first U.S. investigational gene therapy for Duchenne muscular dystrophy in 2006. Evelyn received experimental gene therapy for spinal muscular atrophy in 2015. “Andelyn” combines their names to represent all the families who have courageously participated in the research that makes today’s gene therapies possible. 

Through this journey, we have been able to accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients. We are Turning Hope Into Reality™ through our ACCTSions.

 

ACCOUNTABLE in our actions.

CURIOUS to discover.

COMPASSIONATE in our thinking.         

TRUSTWORTHY in our communications.

SUPPORTIVE of one another.

 

Employees are expected to perform the following essential functions under the framework of our ACCTSions.

 

What you bring to the team.

The Senior Specialist, Quality Systems is an individual contributor role and provides compliance and quality assurance support to all the requirements for the core of the QMS process on the Andelyn organization which supports clinical and commercial GMP production. This position will report to the Quality Manager/Associate Director and will work closely with all the areas of the site operations (Business, M&ST, Validation, Engineering, Quality Control, Quality Assurance, Supply Chain, etc.) and they will ensure compliance to defined Quality System procedures, manage the compliance on the change management process and standards and conduct moderate to high level information analysis. This position will also work collaboratively with the training team to ensure all the areas comply and quality systems. In addition, this position will interact with the different clients in the Change control process.

  • Operate within the Quality Management System applicable to the manufacture of phase appropriate material GMP operations. 
  • Works closely with Operations colleagues of all the areas that required the support of the change management group to ensure control of clinical and commercial manufacturing. Track change controls within the Trackwise system to assure the proper implementation and adequate change management process.
  • Responsible for the Change Control Review Board email distribution list and ensuring that it is kept current and updated, as needed
  • Manage the multiple meetings to coordinate the proper implementation of the change controls and the change management methodology
  • Act as the main point of contact for Change Controls and provide support to owners and approvers assigned in Trackwise
  • Assist in the development of action plans and metrics to monitor Change Management within the Andelyn QMS
  • Act as the owner of the Change Management SOP. Revise, as needed to ensure compliance with regulations and the Andelyn QMS
  • Track Quality Technical Agreements to ensure reviews are performed following applicable SOPs, and compliance with the requirements of the change control process (Change management approach)
  • Additional tasks within QA, as assigned.
  • Operates in alignment with established policies, procedures, and techniques, requiring relevant training, practical experience, or a working knowledge of the tasks involved.
  • Solving, correcting, preventing problems, and performing tasks as assigned by leadership, as well as assigning tasks to junior staff
  • Work to specific measurable objectives requiring operational planning skills with little direct supervision
  • Leads and supports a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contributes to the success of team and goals
  • Documentation of all activities performed according to SOPs
  • Make decisions based on established procedures
  • Other duties as assigned

 

 

What you bring to the team.

 

  • Must possess relevant four-year degree OR relevant Masters OR relevant Ph.D., background in the Sciences (engineering, chemical or biological), life sciences, biotechnology, or gene therapy industries preferred  
  • Five years relevant (w/4 YR deg) OR two years (w/Masters) or 10 years of relevant experience on the area of Change management.  
  • Experience in Pharmaceutical, biologics or gene therapy required  
  • Experience in highly regulated field preferred  
  • Proficient knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 210 & 211, European Directives, ICH guidelines, and cGMP regulations  
  • Experience in commercial and clinical GMP production and ability to provide QA support for both.
  • Experience in Change Management Process and Change Control required.
  • Experience with aseptic manufacturing operations is highly preferred.
  • Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change
  • Must be highly skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting
  • Ability to work independently as well as collaboratively in a diverse and inclusive work environment
  • Must possess a client-focused mindset in daily tasks
  • Must possess prior experience handling confidential information and the ability to maintain confidentiality.

 

What you can expect when working at Andelyn.

  • The pride of contributing to the development and manufacturing of life-saving therapies
  • The invaluable experience of being a part of building the foundation of a new organization.
  • The opportunity to work alongside experts who have over 10 years in the gene therapy field.
  • Competitive compensation
  • Eligible day one for medical, dental, and vision insurance plans with basic vision at 100% company-paid
  • 160 hours of Paid Time Off annually
  • 11 Company Paid Holidays plus 2 floating holidays annually.
  • Company Paid Life Insurance
  • 401(k) Match
  • Company Paid short and long-term disability.
  • 4 weeks of Paid Parental Leave for birth and adoption
  • Adoption Assistance
  • Tuition Reimbursement and Student Loan Repayment Assistance
  • Company Paid LinkedIn Learning access.
  • Employee Assistance Programs
  • Flexible work options (role specific)

 

Andelyn Biosciences embraces diversity and is an equal opportunity employer and does not discriminate based on race, religion, national origin, gender, gender identity, genetic information, sexual orientation, protected veteran status, disability, age, or another legally protected status. As an organization, we are committed to creating an environment where everyone ACCTS.